Skip to main content
OpenTrials
Completed

NCT Number: NCT04484480

Balance and Motion Coordination Parameters Can be Improved in Patients With Type 2 Diabetes

Diabetes mellitus type II (DMII) causes many complications, including retinopathy and peripheral neuropathy. These complications are well understood and believed to contribute to gait instability and increase the risk of falls. Poor balance control and increased falling risk have also been reported in people with diabetic peripheral neuropathy (DPN).

Patients with DPN are at an increased risk of falling due to the decreased proprioceptive feedbacks. Effective balance training should improve instabilities of postural control in patients with DPN. For this purpose, evaluations and balance training was designed.

The goal of our study was to establish values for proprioception, balance, muscle coordination and strength in patients with DMII, who underwent biofeedback balance training using the Biodex Balance System.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 03-984, Poland

About this study

It is estimated that by the end of 2017 year, there will be 462 millions of patients suffering from diabetes mellitus type II (DMII), what is about 6% of world population (4,4% between 15 and 49 years of age, 15% between 50 and 69 years and 22% of patients older than 70 years). It is predicted that by the beginning of 2030, number of cases on 100000 people will grow from 6059 up to 7079. There are studies proving that cardiovascular complications related to the diabetes are responsible for 4 millions of deaths annually. The newest epidemiological data suggest that growing number of DMII cases is no longer a problem in developed countries but also affects developing ones. As potential risk factors, well proved in the literature authors reported alcoholism, nicotinism, high body-mass index (BMI) and positive family history. It is therefore anticipated that the prevalence of one of its common complications, a diabetic peripheral neuropathy (DPN), will increase as well. It is broadly recognized that a DPN leads to a decrement in distal lower limb sensory function; however, there is also a neuropathy-related decrease in distal motor function, even among those with relatively mild diabetic disease. It is well proven in the literature, that diabetes mellitus influences negatively function of peripheral nervous system by damaging sensory fibers. A high risk of falls has been reported in the diabetic population, with an overall incidence of 1.25 falls/person-year.It was proven that short-period strength and balance exercises do not improves diabetic patients quality of life However they have positive influence on the functional outcome of those people. Influence of DMII on motion system is not limited only to the peripheral nervous system. It also affects structures of cerebrum such as: cerebral cortex, cerebellum or basal nuclei. DMII affects motor and somatosensory cerebral atrophy what leads to changes in projection tracts associated with them. In cerebellum it affects on the vermis and parts of lobes responsible for receiving impulses from the spinal cord and controlling proximal parts of muscles, which are crucial for movement coordination during gait. Disorders caused by DMII in basal nuclei result in longer response time and slower gait velocity. Together with pharmacological and dietary interventions, exercise interventions including resistance training, represent the cornerstones of type 2 diabetes management. In addition to the beneficial effects of exercise interventions on glycemic control and on the cardiovascular risk factors associated with type 2 diabetes, physical exercise is an effective intervention to improve muscle strength, power output, cardiovascular function and functional capacity in elderly diabetic patients. In elderly diabetics with severe functional decline, multicomponent exercise programs composed of resistance, endurance, balance and gait retraining should be employed to increase functional capacity and quality of life and to avoid disability and falls. The aim of the study was to evaluate balance and motor coordination parameters in patients treated for type 2 diabetes who received biofeedback-equivalent training using the Biodex dynamometric platform.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • willingness to participate in the study
  • age over 65
  • diagnosed type 2 diabetes, subjected to pharmacological treatment (study group)
  • no type 2 diabetes (control group)

Exclusion criteria

  • unwillingness to participate in the study
  • age below 65 years
  • surgical intervention in the lower limbs or spine during the last 6 months
  • symptoms of osteoarthritis or pain of another origin around the lower limbs or spine
  • rheumatic diseases (eg. rheumatoid arthritis, ankylosing spondylitis)
  • diagnosed neuromuscular disease
  • strongly manifested imbalances due to impairment of central or peripheral nervous system
  • neurological disorders with dizziness, nystagmus, dermatologic or profound (cerebrospinal syndrome, dizziness, multiple sclerosis, Parkinson's disease, etc.).

Treatment and study plan

Balance Training

Procedure

Proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System.

Primary outcomes

  1. Fall risk test

    Time frame: 3-months after inclusion to the study

    Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials. The lower the values of the fall index were, the better the result.

  2. General Stability Index

    Time frame: 3-months after inclusion to the study

    Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials

  3. Frontal-Posterior Stability Index)

    Time frame: 3-months after inclusion to the study

    Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials

  4. Medial-Lateral Stability Index

    Time frame: 3-months after inclusion to the study

    Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Balance and Motion Coordination Parameters Can be Improved in Patients - Non-randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2020
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.